NCT07328074

Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis

Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to explore the effectiveness of electrocautery resection combined with hyperthermic intrathoracic chemotherapy (HITHOC) in patients with thymic epithelial tumors with pleural metastasis or recurrence. The study aims to: * Evaluate whether this combined treatment improves event-free survival in patients with pleural metastasis from thymic epithelial tumors * Assess the rates of grade ≥3 treatment-related adverse events * Examine how this treatment affects patients' quality of life Participants will: * Undergo extended thymectomy with electrocautery resection of pleural metastases * Receive two cycles of hyperthermic intrathoracic chemotherapy with cisplatin and doxorubicin at 42-43°C, 2-4 days apart * Complete quality of life questionnaires (EQ-5D) at baseline and regular intervals * Have regular follow-up visits with imaging and clinical assessments for up to 36 months to monitor for disease recurrence or progression

Conditions

• Thymic Epithelial Tumor
• Thymoma
• Thymic Carcinoma
• Pleural Metastasis
• Pleural Recurrence

Interventions

Type	Name	Description
PROCEDURE	Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermic	Extended thymectomy with electrocautery ablation and resection of pleural metastases. Larger lesions (\>1cm) are thoroughly ablated with electrocautery followed by complete resection. Smaller lesions (≤1cm) that are difficult to resect are thoroughly ablated with electrocautery.
PROCEDURE	Hyperthermic Intrathoracic Chemotherapy (HITHOC)	Two cycles of hyperthermic intrathoracic chemotherapy performed 2-4 days apart using BR-TRG-I device. Chemotherapy solution containing cisplatin (50 mg/m²) and doxorubicin (25 mg/m²) is circulated at 400 mL/min with inflow temperature maintained at 42-43°C for 60 minutes per cycle.

Timeline

• Start date: 2026-02-01
• Primary completion: 2031-02-01
• Completion: 2031-02-01
• First posted: 2026-01-08
• Last updated: 2026-02-05

Locations

1 site across 1 country: China